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Acne
RD.06.SPR.202395 Enrolling

Research Trial for Acne Vulgaris on the Face (28 Weeks)


Age: 17 Years

Individuals aged 17 to 35 years with a clinical diagnosis of acne vulgaris on the face, may qualify to participate. Looking for individuals with moderate or severe facial acne that includes the following:

A minimum of 20 inflammatory lesions (papules and pustules) in total, with at least 10 on each side of the face

– No more than 2 nodules on the face

– A minimum of 10 atrophic acne scars in total

Participants will receive investigational topical medication (active study drug) or placebo, via a cream. Study medication and study-related procedures will be provided at no cost. Reimbursement for study-related expenses may be provided.

Study participation will last about 28 weeks and involve about 10 visits to the study centre.


Official Title

Evaluation of the Risk of Atrophic Acne Scar Formation During Treatment of Acne Vulgaris Subjects With Trifarotene 50 μg/g Cream Versus Vehicle Cream Over 24 Weeks

ClinicalTrials.gov ID

NCT04856904

Sponsor

Galderma R&D

Study Description

  • Brief Summary:

    Galderma R&D

  • Condition or Disease:

    Acne Vulgaris

  • Intervention/Treatment:

    Drug: Trifarotene Vehicle Cream Drug: Trifarotene Cream
  • Phase:

    Phase 4

  • Ages Eligible for Study:

    17 Years and 35 Years (Child,Adult)

  • Sexes Eligible for Study:

    All

Key Inclusion Criteria:

Participant with clinical diagnosis of acne vulgaris on the face as defined by (excluding the nose and middle zone of approximately 2 centimeter [cm]):

Investigator’s Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe), with the same score on both sides of the face; and
A minimum of 20 inflammatory lesions (papules and pustules) in total with at least 10 on each side; and
No more than 2 nodules (greater than or equal to [>=] 1 cm in diameter) on the face; and
A minimum of 10 atrophic acne scars in total (>2 mm)

Participant with a symmetrical number of the following lesions/scars on the whole face:

Inflammatory and non-inflammatory lesions; and
Atrophic acne scars (minimum of 4 scars per half-face)
The participant is a female of non-childbearing potential
If a female of childbearing, potential uses oral contraceptives that are also approve for treating acne vulgaris
Other protocol defined inclusion criteria could apply

Key Exclusion Criteria:

Participant with acne conglobata, acne fulminans, secondary acne, nodulocystic acne and acne requiring systemic treatment
Participant with any acne cyst on the face or with more than 3 excoriated acne lesions
Participant with known active or chronic allergies or suspected allergy to trifarotene or excipients of the formulation
Participant with facial dermal conditions (for example, tattoo, skin abrasion, eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessments in the opinion of the investigator
Participant with known impaired hepatic or renal functions, based on medical history


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Melinda Gooderham

Dermatologist

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Acne

Acne affects more than 85% of teenagers and may frequently continue into adulthood. The cause of acne is unknown, but may include hormones, genetic factors, or stress. While not a life-threatening condition, acne can cause both physical discomfort and a psychological impact regardless of age. Learn More
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